NCT01494987

Ranolazine When Added to Glimepiride in Subjects With Type 2 Diabetes Mellitus

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Ranolazine When Added to Glimepiride in Subjects With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 431 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo-controlled, parallel-group, multi-center study to determine the effect of ranolazine when added to glimepiride on glycemic control in adults with type 2 diabetes mellitus (T2DM) who are inadequately controlled despite current treatment with stable sulfonylurea or metformin therapy in addition to diet and exercise.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Ranolazine	Ranolazine tablet(s) administered orally
DRUG	Placebo	Placebo to match ranolazine for the duration of the study
DRUG	Glimepiride	Glimepiride tablets (2 mg or 4 mg) administered orally once daily with the morning dose of study drug or placebo. The target dosing regimen for glimepiride is 4 mg once daily.
BEHAVIORAL	Diet	Participants are instructed to continue the diet regimen prescribed by their physician.
BEHAVIORAL	Exercise	Participants are instructed to continue the exercise regimen prescribed by their physician.

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2011-12-19
• Last updated: 2014-11-18
• Results posted: 2014-09-01

Locations

140 sites across 12 countries: United States, Czechia, Hungary, Malaysia, Poland, Romania, Russia, Serbia, Slovakia, South Africa, Thailand, Ukraine